I guess my followup question would be if you do determine there are "training requirements" needed, is it sufficient to merely document that in the IFU?
Bear in mind that 7.2.1(d) is, effectively, a design input. When you develop your product, are there requirements for training the end user. Per my previous post, if you're introducing something novel into the market, you're probably going to establish requirements for training. Those requirements would be elaborated as training materials, training courses, etc. Training is not, IMO, the role of the IFU. And the IFU is a design output.
We've had an auditor who had told us we can't count on a customer reading the IFU and automatically point to that whenever there's a use error identified
This is exactly why the usability standard (62366) is getting more focus and the focus of several of the changes to 14971 (can't rely on labeling alone for risk reduction).
If there was a complaint filed where the customer was determined to have misused the product (meaning they did not follow the IFU), does this requirement mean you need to send someone to give your customer hands on training?
This brings the issue full circle. If you have a complaint then you need to assess it for risk, etc. If the complaint is with usability, you need to determine if the design is sufficient to ensure no hazards are realized and, if not, a design change is probably warranted. If you're following 62366, you'll have the tools in place to assess the UI and determine if this is a systemic issue or just a one-off. If systemic, you'll probably want to change the UI to reduce the likelihood of additional, similar complaints. If the UI is sound, you may then look to additional training methods.
I think our IFU covers just about everything, however I was thinking (perhaps incorrectly) that this 7.2.1(d) might require something a bit more formal than the IFU. I wouldn't really call the IFU "training" per-say either--- just because you give someone a set of instructions doesn't mean they are "trained"
We (in test) have a philosophy: if something can go wrong, there WILL be a user that will find it. IFUs are typically written from the 'expert' point of view, considering primarily the right way to do things. Users aren't so much the case! That's why the UI and design play such critical factors in usability and error prevention. Training is one tool in the toolbox but then you have to consider training effectiveness and training coverage (you may train one person in an office and then rely on them to train the rest of the staff... how effective can that be?).
Sorry for getting a bit off topic and babbling on about design stuff but, indeed, there's a big picture to consider when you talk about training and customer complaints.